Sanitaz SkinPROTECT Hand Sanitizer

Sanitaz SkinPROTECT Hand Sanitizer by

Drug Labeling and Warnings

Sanitaz SkinPROTECT Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Sanitaz Inc., Genesis Custom Chemical Blending, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SANITAZ SKINPROTECT HAND SANITIZER- alcohol gel 
Sanitaz Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Sanitaz SkinPROTECT Hand Sanitizer

Active Ingredient(s)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

• in children less than 2 months of age
• on open skin wounds

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Place enough product on hands to cover all surfaces. Rub hands together until dry.
• Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

purified water USP, acrylates copolymer, tocopheryl acetate (vitamin E), glycerin, propylene glycol, diisopropyl sebacate, aminomethyl propanol, polysorbate 80.

Package Label - Principal Display Panel

1249184.6 mL; 300 gallons NDC: 77497-120-99

Package Label - Principal Display Panel

473.2 mL (16 oz) 77497-120-16

Package Label - Principal Display Panel

8 oz. 236.6 mL NDC: 77497-120-08

Package Label - Principal Display Panel

NDC: 77497-120-11; 3785.4 mL; 1 Gal

SANITAZ SKINPROTECT HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77497-120
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C)
GLYCERIN (UNII: PDC6A3C0OX)
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77497-120-99	1249184.6 mL in 1 TANK; Type 0: Not a Combination Product	09/21/2020	12/31/2021
2	NDC: 77497-120-08	236.6 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/16/2020	12/31/2021
3	NDC: 77497-120-16	473.2 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/09/2020	12/31/2021
4	NDC: 77497-120-11	3785.4 mL in 1 JUG; Type 0: Not a Combination Product	11/30/2020	12/31/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/21/2020	12/31/2021

Labeler - Sanitaz Inc. (117685363)

Revised: 1/2022

Document Id: d43ca3e8-4c3b-e978-e053-2a95a90a0867

34390-5

Set id: af6fde29-37bb-fefc-e053-2a95a90ad403

Version: 3

Effective Time: 20220104

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